Seventeen countries are hosting sites for the Phase 3 efficacy trials of a monthly PrEP pill, MK-8527, being developed by Merck (also known as MSD outside of the US and Canada). Merck announced the launch of the Phase 3 trials at IAS 2025 in Kigali. MK-8527 was found to be safe and well-tolerated in Phase 2 clinical trials.
EXPrESSIVE Phase 3 Trials Countries of MK-8527
Source of Lenacapavir for PrEP Supply to Early Adopter Countries
The Global Fund, with support from CIFF, and PEPFAR have jointly committed to reaching up to two million people with injectable lenacapavir for PrEP over three years. Supply of LEN began arriving in countries in late 2025 with service delivery planned to start in early 2026.
An “Innovation Pile-Up” in Next-Generation LA-PrEP is Possible
The HIV prevention market is headed toward a period of significant opportunity—and possible congestion—as a slate of new products are on track for continued development and potential introduction to the market in 2027 and 2028. Markets and policies must be built to support the products in the market already, so that new options can be rapidly deployed and deliver impact. Otherwise, the field will squander time and money, with epidemic control slipping further out of reach.
Dapivirine Vaginal Ring Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
Lenacapavir Implementation Studies
Ongoing and planned implementation studies for the lenacapavir as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
HIV Prevention Product Overview
The graphic provides an overview of PrEP products currently available and in late-stage clinical trials.
Lenacapavir Regulatory Approval
Regulatory approvals, pending decisions, and appeals as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
People’s Research Agenda 2025 Update Summary Table
The People’s Research Agenda sets out a people-centered framework for equitable and accelerated R&D and product introduction. It tracks the science, shows where investments align—or fail to align—with community-defined priorities, and spotlights critical gaps in the pipeline of prevention options needed to meet the diverse realities of all populations. View this summary table or see the full report and dashboard.
Cabotegravir Regulatory Approval
Regulatory approvals and those pending for cabotegravir as of January 2026. For product approvals, volumes, implementation, and price comparisons of long-acting PrEP, visit our dashboard on PrEPWatch.org.
HIV Vaccine Clinical Trials Pipeline
This graphic summarizes the state of HIV vaccine research, detailing the different immunological approaches in clinical trials, the specific candidates being studied, and the collaborative networks of funders and developers working toward an effective vaccine.